A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe rheumatoid arthritis. This study was an extension of a multinational, multi-center phase III study of SB2, which had reported results…
On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that provide definitions for relevant terminology, describe the biosimilar approval process, and explain the benefits of biosimilars. FDA also created social media posts for external…
Further to our update yesterday on the Amgen v. Hospira litigation, the parties in the case filed several additional motions yesterday. Following its filing of a motion for judgment as a matter of law under Federal Rule of Civil Procedure 50(a) last month, Hospira has now filed a renewed motion for judgment as a…
As we previously reported, on September 22, 2017, a Delaware federal jury awarded Amgen $70 million in damages after finding that Hospira infringed one of Amgen’s Epogen® (EPO) patents (the ’298 patent). Five days later, Hospira filed a motion under FRCP 50(a) for judgment as a matter of law that…
We reported earlier that on October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that MVASITM (bevacizumab-awwb), Amgen’s recently approved biosimilar of Avastin®, does not infringe 27 patents, that those patents are invalid, and that one of the patents is unenforceable for…
On October 19, 2017, Abzena plc and UGA Biopharma Gmbh announced that their partnership completed development of an NS0 (murine myeloma) manufacturing cell line. This cell line expresses a biosimilar of a therapeutic antibody for multiple sclerosis. While the press release does not disclose the originator therapeutic, it notes the…
We reported earlier this month that, in early October, Genentech filed a complaint under seal against Amgen in the District of Delaware based on Amgen’s FDA-approved aBLA for MVASI® (bevacizumab-awwb), a biosimilar of Avastin®. Yesterday, a redacted version of that Complaint became available on the public docket. There is also a…
Intas, an Indian pharmaceutical company based in Ahmedabad, has launched BEVATAS (bevacizumab), a biosimilar to Roche’s AVASTIN, in India. Bevacizumab is used to treat colorectal cancer, ovarian cancer, cervical cancer, lung cancer and recurrent glioblastoma. Bevacizumab has been available in India since 2004. Intas’s BEVATAS product is priced at 40%…
Today, Judge Bryson, a Federal Circuit judge sitting by designation in the U.S. District Court for the Eastern District of Texas, Marshall Division, issued an Opinion and Order granting Allergan’s motion to join the St. Regis Mohawk Tribe (“the Tribe”) as a party to this litigation regarding the drug Restasis®. …
The Federal Trade Commission (FTC) is hosting a workshop on November 8, 2017 at the Constitution Center in Washington, DC entitled: “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop will address, among other things, competition for biologics under the BPCIA framework. The workshop will be…